Recognition List Number: 030 Publication Date: 01/15/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-105: IEC 60601-2-25 Edition 2.0 2011-10, Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs. (Cardiovascular)
Date of Standard: 2011. |
| Address of Standards Organization: |
| International Electrotechnical Commission (IEC) |
| 3, Rue de Varembe' |
| PO Box 131 |
| CH-1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF CARDIOVASCULAR DEVICES (DCD) |
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| Devices Affected: |
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| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
Complete Standard for SAFETY ONLY (Including Protection Against Electric Shock Hazards) for Type CF EQUIPMENT or APPLIED PART
(Note: Standard is NOT applicable for equipment labeled and tested as Type B or BF EQUIPMENT or APPLIED PART).
Therefore, Clause 201.7.9.2.101 a)2) of the particular standard applies to only type CF electrocardiographs, not Types B or BF.
Clauses 201.12.1.101.2, 201.12.1.101.3.1 and 201.12.1.101.3.2. in the particular standard are not recognized.
Clause 201.8.5.5.1 of the particular standard is not recognized.
Clause 201.8.5.2.3 of the particular standard is not recognized (SEE 21 CFR 898).
NOTE: FDA may request performance data since the IEC particular standard only deals with safety. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §870.2340 |
Electrocardiograph |
Class 2 |
DPS |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contacts: |
| Charles Ho, Ph.D. |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1318 |
| Silver Spring MD 20993 |
| 301/796-6320 |
| Email: charles.ho@fda.hhs.gov |
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| Frank Lacy |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1236 |
| Silver Spring MD 20993 |
| 301/796-6321 |
| Email: frank.lacy@fda.hhs.gov |
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| Linda Ricci |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1246 |
| Silver Spring MD 20993 |
| 301/796-6325 |
| Email: linda.ricci@fda.hhs.gov |
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